NCT03420066

The NEXUS™ Compassionate Use Data Collection Study

NEXUS™ Aortic Arch Stent Graft System Data Collection Study for Compassionate-Use Procedures

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 7 (actual)
• Sponsor: Endospan Ltd. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

A Multicenter, observational Data Collection Study to Evaluate the Safety and Performance of the Nexus™ Aortic Arch Stent Graft System in patients that were implanted with the device as part of Compassionate Use Procedures.

Detailed description

The purpose of the study is to collect and analyze data that is recorded as standard of care for patients that were implanted with the Nexus device as part of Compassionate Use Procedures.The data will be used to obtain additional information on the safety and performance of the Nexus™ Aortic Arch Stent Graft System in patients affected by pathologies involving the aortic arch. Data will be collected at each time point of patient's follow up conducted according to the standard of care in each site.

Conditions

• Aortic Arch Aneurysm

Interventions

Type	Name	Description
OTHER	Retrospective data collection	Retrospective collection of data recorded as standard of care for patients that were implanted with the Nexus device as part of Compassionate Use duly authorized according to country specific regulations.

Timeline

• Start date: 2018-02-19
• Primary completion: 2018-09-14
• Completion: 2023-11-28
• First posted: 2018-02-05
• Last updated: 2024-01-05

Locations

4 sites across 3 countries: Italy, New Zealand, Switzerland